FDA UDI
Not in Commercial Distribution
🇺🇸 United States
GAS TAPE
DI: 10732224730209
·
Model: GT-048
·
SPS Medical Supply Corp.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- GAS TAPE
- Primary DI
- 10732224730209
- Version / Model
- GT-048
- Catalog Number
- GT-048
- Company Name
- SPS Medical Supply Corp.
- Labeler DUNS
- 194877072
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-15
- Public Version
- 4
- Public Version Date
- 2023-08-25
- Public Version Status
- Update
- Public Device Record Key
- 9afcfd1f-316a-4504-ab5a-0adce520e0dc
- Distribution End Date
- 2023-08-24
Device Description
Indicator tape provides identification of EO gas-processed items while also securing sterilization packs.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JOJ | Indicator, physical/chemical sterilization process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35362 | Chemical/physical sterilization process indicator | A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50732224730207 | GS1 | roll | 24 | Not in Commercial Distribution | 2023-08-24 |
| Primary | 10732224730209 | GS1 |
Customer Contacts
- Phone
- +1(585)359-0130
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 60 | Yard | |
| Width | 0.75 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Controlled room temperature per USP